176 / 620
Single Lab Validation Report for GOS in Infant Formula and Adult Nutritionals
10
Figure 8: Residue plot of the deviation from the actual concentration by quadratic calibration for lactose
3.2
Precision
Only three of the fortified products contained GOS. They were all analyzed in duplicate on three
different days on two instruments. Raw data is given in Appendix 5.2 and Table 2 shows the summarized
results.
Table 2: Assessment of method precision using three SPIFAN kit matrices
Sample
Level (g/100g)
%RSD(r)
%RSD(R)
Meets SMPR
requirements?
8 IF Powder Partially Hydrolyzed
Milk Based (1172572116)
0.309
1.9
4.1
Yes
13 Infant Formula Powder Milk
Based (D04HTCVV)
0.235
3.7
4.4
Yes
15 Infant Formula RTF Milk Based
(SPIFAN Control Milk Form)
0.189
2.0
9.9
Yes
The SPMR requires that RSD(r) and RSD(R) are ≤ 6% and ≤ 12%, respectively. Therefore, precision criteria
are met.
3.3
Accuracy
Four of the SPIFAN kit matrices were selected for use in spike-recovery experiments. Each matrix was
spiked at 4 levels with Vivinal or Clasado GOS according to the scheme described in Table 1. The raw
data is available in Appendix 5.3 and is summarized in Table 3.
-10
-8
-6
-4
-2
0
2
4
6
8
0.00
5.00
10.00
15.00
20.00
% deviation from actual concentration
Lactose Concentration (µg/mL)
Residue Plot Lactose Quadratic
GOS-02 SLV
FOR ERP USE ONLY
DO NOT DISTRIBUTE